Label: DOMETUSS-G- guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Guaifenesin200 mgExpectorant
    Dextromethorphan HBr20 mgCough Suppressant
    Phenylephrine HCl10 mgNasal Decongestant
  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily reduces cough due to minor throat and bronchial irritation associated with a cold
    • calm the cough control center, and relieves coughing.
    • Temporarily relief nasal congestion due to the common cold
    • hay fever or other upper respiratory allergies
    • sinus congestion and pressure
  • Warnings

    • Do not exceed recommended dosage

    If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.

    Do not use

    • if you are now taken a prescription Monoaminoxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product

    Do not take this product: for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.

    Do not give this product if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

    Ask a doctor before use if you have

    • liver disease
    • if you are taking the blood thinning drug warfarin.

    Stop using this product and ask a doctor if

    • new symptoms occur
    • symptoms do not improve within 7 days or are accompanied by fever.
    • pain or fever persists or gets worse. These could be signs of a serious condition

    Keep out of reach of children.

    If you are pregnant or breast-feeding, ask a health professional before use.

  • Directions

    Do not take more than 6 doses in any 24 hours period.

    AgeDose
    adults and children 12 years of age and over1 tablets every 4 hours.
    children 6 to 12 years of age1/2 tablet every 4 hours.
    children under 6 years of ageConsult a doctor.
  • Other information

    • store at room temperature 15°- 30°C (59° - 86°F).

    Tamper evident

    Do not use if there is evidence of tampering.

  • Inactive ingredients

    Dicalcium phosphate, magnesium stearate, maltodextrin, mirocrystalline cellulose, povidone, silicon dioxide, stearic acid, talc.

  • Questions or comments?

    Calle de Diego #488
    San Juan P.R. 00924

    Phone: 787-767-3246
    For more information visit
    www.domelpharma.com

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    NDC 53809-250-01

    DOMETUSS-G

    DEXTROMETHORPHAN HBr/
    PHENYLEPHRINE HCl / GUAIFENESIN

    • Cough Suppressant
    • Nasal Decongestant
    • Expectorant

    100 TABLETS

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    DOMETUSS-G 
    guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-250
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code D2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53809-250-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2019
    2NDC:53809-250-044 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01211/11/2019
    Labeler - DOMEL (808198837)
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